Agile Therapeutics Stock Offering Only a Short-Term Setback After Twirla Approval

Posted on February 21, 2020 by Medtech[y] Staff

Agile Therapeutics stock (Nasdaq: AGRX) is down another 13% after announcing the pricing of the stock offering announced yesterday. Agile is offering 15 million shares at a public offering price of $3.00 per share.

Agile's stock has been on a wild ride since getting a surprise Valentine's Day gift from the FDA after the agency approved their Twirla transdermal system. The weekly contraceptive patch delivers a 30 MCG daily dose of estrogen and 120 MCG daily dose of progestin.

“The FDA’s approval of Twirla will enable us to deliver on our short-term goal of establishing Agile in the contraceptive prescription market and working towards our longer-term mission to broaden our women’s health portfolio, including in areas of unmet need. We are grateful to the clinical trial patients, researchers, healthcare providers, and advocates, whose contributions helped us secure the approval of a new transdermal contraceptive option that may serve the contraceptive needs and preferences of many women,” said Al Altomari, chairman and chief executive officer, Agile Therapeutics. "We are proud to offer this new option and look forward to bringing Twirla to women and their healthcare providers.”

Getting approval for the company's first product is exciting, but now the real work begins as Agile ramps up their commercial activities.

In the first quarter, Agile plans to initiate work with managed care and patient payors to gain market access for Twirla. Beginning in the second quarter of 2020, Agile will begin hiring and training an initial sales team. During this time, Agile will also complete the validation of its commercial manufacturing process and expects to ship initial product to wholesalers in the fourth quarter of 2020.

While Twirla received regulatory approval, the FDA is requiring Agile to conduct a long-term prospective, observational post-marketing study to compare the risks for venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla to new users of other combined hormonal contraceptives (CHC).

The final study report for the Twirla study is scheduled to be submitted to the FDA in November 2032, with interim safety data reporting to the FDA due in November 2026.

Additionally, Agile agreed to a post-marketing commitment (PMC) study to assess the residual drug content and strength of Twirla in a minimum of 25 women, which will analyze the Twirla ethinyl estradiol and levonorgestrel content after the prescribed wear and will monitor adhesion. Agile plans to begin designing the post-approval studies and evaluating related costs during the first half of 2020.

As to Agile's market opportunity, the company estimates that Twirla can potentially achieve a peak market share of 5-8% based on the potential new CHC users who have a BMI <30 kg/m2, which represents a significant population of women.

“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives,” said Dr. David Portman, a primary investigator on the SECURE clinical trial. “I’m pleased that Agile conducted a comprehensive study in a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle. I am excited healthcare providers can now include Twirla among available contraception options.”

An offering after approval or any positive news is nothing new to Biotech investors. It's expected. Now it comes down to how they execute going forward. Who knows, maybe they don't even need the sales team they plan on hiring, and end up getting acquired prior to their full commercial launch. It wouldn't be shocking.